To use the catheter, the patient will first select a sleeve, slide it over the sensor, and place a fastener tip on the end of the sensor. The catheter is then inserted into the rectum. A small amount of lubricant may be used to make insertion easier.

Next, the patient will attach a syringe to the check valve on the opposite end of the catheter and inflate the balloon with a prescribed amount of air, sealing the rectum so that fecal matter will not be passed accidentally.

Finally, the patient will plug the connector into the patient notification box and press the button to turn it on. At this point, the patient can proceed with normal activities.

The ProTect™will then monitor the rectum for fecal matter. When it is detected, the patient notification box will notify the patient by either vibrating or beeping, according to the patient's choice. The alarm is stopped by pressing the button on the patient notification box.

When the patient has found a restroom and is ready to eliminate the fecal matter, he or she simply uses the syringe to deflate the balloon cuff and withdraws the catheter, allowing the fecal matter to pass out of the rectum and into the toilet. The catheter can then be cleaned and reused. A single catheter can be used for up to 28 days of actual time in the body.

Using the ProTect™ system:

• Select a sleeve. The sleeve with round holes should be used if loose, watery stool is expected. The slotted sleeve should be used if firmer stool is expected.

• Place the sleeve over the tip of the ProTect™catheter. If you are using the slotted sleeve, turn it on the catheter tip until it locks into position. The sleeve with round holes does not need to lock into position.

• Place a fastening tip over the tip of the catheter to hold the sleeve in place.

• Insert the ProTect™catheter into the rectum as directed by your physician. A small amount of lubricant may be used to make insertion easier. DO NOT USE AN OIL BASED LUBRICANT.

• Draw the amount of air into the ProTect™syringe that was prescribed by your physician. Attach the syringe to the catheter valve and inject the air into the catheter's balloon cuff, then remove the syringe.

• Connect your ProTect™catheter to the Patient Notification Box.

• Turn on the Patient Notification Box by pressing the button on the front. The box will vibrate or beep twice (depending on the mode setting) and the green LED will be lit for approximately 2 seconds to let you know the system has been turned on. If the box vibrates or beeps continuously when it is first turned on, it is because there is a problem with the catheter. Remove it and replace it with another catheter. Return the problem catheter to your physician.

• Attach the Patient Notification Box to your clothing or slip it into your pocket and proceed with your normal daily activities.

While the ProTect™ is Working:

• The green LED will blink approximately once every 5 seconds to let you know that the unit is on and working. You may turn the system off at any time by pressing the button. The red LED will be lit for approximately 2 seconds to confirm that the unit was turned off.

• If the battery is low, the red LED will blink every 5 seconds instead of the green LED. The unit is still working, but the battery in the Patient Notification box should be changed as soon as possible.

• If the red LED is lit solidly (not blinking) then the battery is so low that the Patient Notification Box cannot function. The battery must be replaced for the Patient Notification Box to function.

• If the red and green LEDs both blink every 5 seconds, the catheter is expired. The system will still work, but the catheter must be replaced before the Patient Notification Box is turned on again. If the catheter is left in for more than 24 hours beyond expiration, the Patient Notification box will alarm. The Patient Notification Box will alarm immediately when turned on if an expired catheter is used.

When the ProTect™ Alarms

• When the ProTect™system detects feces in the rectum, it will notify you by beeping or vibrating (depending on the mode setting). You may stop the alarm by pressing the button to turn the system off. The red LED will be lit for approximately 2 seconds to confirm that the unit was turned off. You should find an appropriate place and evacuate as soon as possible.

• Disconnect the ProTect™catheter from the Patient Notification Box.

• Attach the syringe to the catheter valve and remove the air from the balloon cuff.

• Remove the catheter and evacuate feces.

• Clean the catheter or store it in an airtight bag for later cleaning.

• Install a clean catheter using the steps described above in Using the ProTect™ system.

Cleaning the ProTect™ Catheter

• Clean the ProTect™catheter using warm, soapy water and a soft cloth. You may use a cotton swab for cleaning small areas. Do not allow water to get into the tube.

• Rinse the catheter with clean water.

• Allow to dry before reuse.

• It is recommended that you replace the fastener cap each day.